This study aims to find a safe and effective dose of BI 754091. The study also aims to find safe and effective doses of BI 754091 and BI 754111 in combination. This study is done in Asian patients with different types of cancer
- Conditions
- Solid Tumor
- Registration Number
- JPRN-jRCT2080223817
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 164
1.Of full age (according to local legislation) at the time of signing of the informed consent form (ICF)
2.Women of childbearing potential (WOCBP) with negative serum pregnancy test at screening and men able to father a child, who agree to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. The requirement of contraception does not apply to women of no childbearing potential but they must have an evidence of such at screening
3.Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
etc.
1.Major surgery (major according to the investigators assessment) performed within 12 weeks prior to study entry or planned within 12 months after screening, e.g. hip replacement
2.Patients who must or wish to continue the intake of restricted medications (see Section 4.2.2.2) or any drug considered likely to interfere with the safe conduct of the trial
3.Previous treatment with study medications in this trial
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>exploratory<br>MTD<br>Number of DLT<br>OR
- Secondary Outcome Measures
Name Time Method efficacy<br>exploratory<br>pharmacokinetics<br>pharmacogenomics<br>PK including Cmax and AUC0-504<br>safety<br>efficacy<br>exploratory<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>other<br>DOR